Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045487
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2002-09-06
Brief Title:
Erlotinib in Treating Patients With Advanced Kidney Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Pharmacokinetic And Biologic Correlative Study of OSI-774 An EGFR Tyrosine Kinase Inhibitor In Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSI-774
Brief Summary:
RATIONALE Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer
PURPOSE Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma
Evaluate the safety and tolerability in terms of the toxicity profile of this drug in these patients
Determine the biologic activity of this drug in terms of early disease progression progression-free survival 12-month survival rate and overall survival in these patients
Determine the pharmacodynamics of this drug in these patients
Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle apoptosis and angiogenesis in tumor biopsies from these patients
Correlate changes in biological measurements with indices of outcome in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 19-40 patients will be accrued for this study within 8-10 months
Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma
Evaluate the safety and tolerability in terms of the toxicity profile of this drug in these patients
Determine the biologic activity of this drug in terms of early disease progression progression-free survival 12-month survival rate and overall survival in these patients
Determine the pharmacodynamics of this drug in these patients
Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle apoptosis and angiogenesis in tumor biopsies from these patients
Correlate changes in biological measurements with indices of outcome in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 19-40 patients will be accrued for this study within 8-10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5410 | OTHER | National Cancer Institute NCI | None |
| IDD 01-27 | OTHER | None | None |